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  • 1
    In: BMJ Open Respiratory Research, BMJ, Vol. 8, No. 1 ( 2021-09), p. e000939-
    Abstract: To evaluate the performance of direct-to-consumer pulse oximeters under clinical conditions, with arterial blood gas measurement (SaO 2 ) as reference standard. Design Cross-sectional, validation study. Setting Intensive care. Participants Adult patients requiring SaO 2 -monitoring. Interventions The studied oximeters are top-selling in Europe/USA (AFAC FS10D, AGPTEK FS10C, ANAPULSE ANP 100, Cocobear, Contec CMS50D1, HYLOGY MD-H37, Mommed YM101, PRCMISEMED F4PRO, PULOX PO-200 and Zacurate Pro Series 500 DL). Directly after collection of a SaO 2 blood sample, we obtained pulse oximeter readings (SpO 2 ). SpO 2 -readings were performed in rotating order, blinded for SaO 2 and completed 〈 10 min after blood sample collection. Outcome measures Bias (SpO 2 –SaO 2 ) mean, root mean square difference (A RMS ), mean absolute error (MAE) and accuracy in identifying hypoxaemia (SaO 2 ≤90%). As a clinical index test, we included a hospital-grade SpO 2 -monitor (Philips). Results In 35 consecutive patients, we obtained 2258 SpO 2 -readings and 234 SaO 2 -samples. Mean bias ranged from −0.6 to −4.8. None of the pulse oximeters met A RMS ≤3%, the requirement set by International Organisation for Standardisation (ISO)-standards and required for Food and Drug Administration (FDA) 501(k)-clearance. The MAE ranged from 2.3 to 5.1, and five out of ten pulse oximeters met the requirement of ≤3%. For hypoxaemia, negative predictive values were 98%–99%. Positive predictive values ranged from 11% to 30%. Highest accuracy (95% CI) was found for Contec CMS50D1; 91% (86–94) and Zacurate Pro Series 500 DL; 90% (85–94). The hospital-grade SpO 2 -monitor had an A RMS of 3.0% and MAE of 1.9, and an accuracy of 95% (91%–97%). Conclusion Top-selling, direct-to-consumer pulse oximeters can accurately rule out hypoxaemia, but do not meet ISO-standards required for FDA-clearance
    Type of Medium: Online Resource
    ISSN: 2052-4439
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2736454-9
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  • 2
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 132, No. suppl_3 ( 2015-11-10)
    Abstract: Background: Hybrid coronary revascularization (HCR), which combines minimally invasive bypass surgery and percutaneous coronary intervention of non-LAD vessels, constitute a less invasive alternative to conventional coronary artery bypass grafting (CABG). The safety and effectiveness of HCR in acute coronary syndromes (ACS) as a surgical coronary revacularization strategy is unknown. Methods: Patients presenting with ACS who underwent HCR at a U.S. academic center (1/2008-9/2013) were included. These patients were matched 1:4 to similar individuals who underwent CABG using a propensity-score matching algorithm. Conditional logistic regression and Cox regression stratified on matched pairs were performed to evaluate the association of HCR versus CABG on the outcomes of 30-day MACCE (a composite of mortality, myocardial infarction (MI) and stroke), peri-procedural complications, and 3-year mortality. Results: Of 585 patients (HCR=117, CABG=468) in the propensity-score matched cohort, the 30-day MACCE was comparable after HCR and CABG (4.3% vs. 3.6%, odds ratio: 1.19, 95%-CI:0.43-3.19, p=0.75). Compared with CABG, HCR resulted in fewer procedural complications (7.7% vs. 16.0%, p=0.037), fewer blood transfusions (0 95%-CI:0-0 vs 1 95%-CI:0-2, p 〈 0.001), lower chest-tube drainage (760cc 95%-CI:555-1090 vs. 890cc 95%-CI:660-1130, p 〈 0.001) and shorter length-of-stay (4, 95%-CI:3-5 versus 5, 95%-CI:4-7 days, p 〈 0.001). Over a 3-year follow-up period, mortality was similar after HCR and CABG (6.0% vs. 7.0%, hazard ratio: 0.92, 95%-CI:0.33-2.54, p=0.87). Conclusion: In this exploratory analysis we found that among patients with ACS the use of HCR appeared safe, with fewer procedural complications, less blood product use, and faster recovery with similar longitudinal outcomes relative to conventional CABG surgery. Future multi-center studies involving a large number of patients with ACS are needed to confirm these findings.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1466401-X
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  • 3
    In: BMJ Open, BMJ, Vol. 10, No. 9 ( 2020-09), p. e039091-
    Abstract: Major ECG abnormalities have been associated with increased risk of cardiovascular disease (CVD) burden in asymptomatic populations. However, sex differences in occurrence of major ECG abnormalities have been poorly studied, particularly across ethnic groups. The objectives were to investigate (1) sex differences in the prevalence of major and, as a secondary outcome, minor ECG abnormalities, (2) whether patterns of sex differences varied across ethnic groups, by age and (3) to what extent conventional cardiovascular risk factors contributed to observed sex differences. Design Cross-sectional analysis of population-based study. Setting Multi-ethnic, population-based Healthy Life in an Urban Setting cohort, Amsterdam, the Netherlands. Participants 8089 men and 11 369 women of Dutch, South-Asian Surinamese, African Surinamese, Ghanaian, Turkish and Moroccan origin aged 18–70 years without CVD. Outcome measures Age-adjusted and multivariable logistic regression analyses were performed to study sex differences in prevalence of major and, as secondary outcome, minor ECG abnormalities in the overall population, across ethnic groups and by age-groups (18–35, 36–50 and 〉 50 years). Results Major and minor ECG abnormalities were less prevalent in women than men (4.6% vs 6.6% and 23.8% vs 39.8%, respectively). After adjustment for conventional risk factors, sex differences in major abnormalities were smaller in ethnic minority groups (OR ranged from 0.61 in Moroccans to 1.32 in South-Asian Surinamese) than in the Dutch (OR 0.49; 95% CI 0.36 to 0.65). Only in South-Asian Surinamese, women did not have a lower odds than men (OR 1.32; 95% CI 0.96 to 1.84). The pattern of smaller sex differences in ethnic minority groups was more pronounced in older than in younger age-groups. Conclusions The prevalence of major ECG abnormalities was lower in women than men. However, sex differences were less apparent in ethnic minority groups. Conventional risk factors did not contribute substantially to observed sex differences.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2599832-8
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  • 4
    In: European Heart Journal: Acute Cardiovascular Care, Oxford University Press (OUP), Vol. 6, No. 2 ( 2017-03), p. 155-163
    Type of Medium: Online Resource
    ISSN: 2048-8726 , 2048-8734
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2017
    detail.hit.zdb_id: 2663340-1
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  • 5
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 132, No. suppl_3 ( 2015-11-10)
    Abstract: Objectives: To describe treatment strategies of patients with prior coronary artery bypass grafting (CABG) who underwent subsequent coronary angiography and to compare clinical outcomes among patients who underwent coronary revascularization (CR) versus optimal medical therapy (OMT). Methods: From patients with prior CABG who underwent subsequent non-emergent coronary angiography at Duke University Hospital between January 2003 and October 2012, we identified those with documented stenosis of at least one vessel (native or bypass graft). All patients were followed for subsequent death, MI, or stroke through December 2013. Logistic and Cox-proportional hazards regression models were used for 30-day and 5-year outcomes, respectively. Results: A total of 3838 patients were included, of whom 1,672 (43.6%) were treated with CR within 30 days of index catheterization (1615 with PCI and 57 with CABG) and 2,166 (56.4%) received OMT. Median age was 66 (IQR 58-74) years; 26.5% were women. Heart failure was more common in the OMT group (NYHA 〉 II, 11.6% vs. 19.7%); ACS was more common in the CR group (44.7% vs. 36.6%). Rates of death, MI, or stroke were 2.4% in both groups at 30 days and 41.2% and 40.6% for CR and OMT, respectively, at 5-years (Figure 1). Adjusted death, MI or stroke rates were similar between groups at 30 days (OR: 1.05, 95% confidence interval (CI): 0.66-1.65, p=0.85) and 5 years (OR: 1.08, 95%-CI: 0.97-1.20, p=0.18). Five-year death or MI (OR: 1.04, 95% CI: 0.93-1.17, p=0.46) and all-cause mortality (OR: 0.93, 95% CI: 0.82-1.06, p=0.26) were also similar. Conclusion: Among patients with prior CABG who undergo subsequent coronary angiography, long-term outcomes are poor. In a non-randomized comparison, clinical outcomes with CR are similar to those for OMT.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1466401-X
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  • 6
    In: Family Practice, Oxford University Press (OUP), Vol. 38, No. 2 ( 2021-03-29), p. 70-75
    Abstract: Handheld single-lead electrocardiograms (1L-ECG) present a welcome addition to the diagnostic arsenal of general practitioners (GPs). However, little is known about GPs’ 1L-ECG interpretation skills, and thus its reliability in real-world practice. Objective To determine the diagnostic accuracy of GPs in diagnosing atrial fibrillation or flutter (AF/Afl) based on 1L-ECGs, with and without the aid of automatic algorithm interpretation, as well as other relevant ECG abnormalities. Methods We invited 2239 Dutch GPs for an online case-vignette study. GPs were asked to interpret four 1L-ECGs, randomly drawn from a pool of 80 case-vignettes. These vignettes were obtained from a primary care study that used smartphone-operated 1L-ECG recordings using the AliveCor KardiaMobile. Interpretation of all 1L-ECGs by a panel of cardiologists was used as reference standard. Results A total of 457 (20.4%) GPs responded and interpreted a total of 1613 1L-ECGs. Sensitivity and specificity for AF/Afl (prevalence 13%) were 92.5% (95% CI: 82.5–97.0%) and 89.8% (95% CI: 85.5–92.9%), respectively. PPV and NPV for AF/Afl were 45.7% (95% CI: 22.4–70.9%) and 98.8% (95% CI: 97.1–99.5%), respectively. GP interpretation skills did not improve in case-vignettes where the outcome of automatic AF-detection algorithm was provided. In detecting any relevant ECG abnormality (prevalence 22%), sensitivity, specificity, PPV and NPV were 96.3% (95% CI: 92.8–98.2%), 68.8% (95% CI: 62.4–74.6%), 43.9% (95% CI: 27.7–61.5%) and 97.9% (95% CI: 94.9–99.1%), respectively. Conclusions GPs can safely rule out cardiac arrhythmias with 1L-ECGs. However, whenever an abnormality is suspected, confirmation by an expert-reader is warranted.
    Type of Medium: Online Resource
    ISSN: 1460-2229
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 1484852-1
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  • 7
    In: Family Practice, Oxford University Press (OUP), Vol. 40, No. 1 ( 2023-02-09), p. 188-194
    Abstract: Timely diagnosis of heart failure (HF) is essential to optimize treatment opportunities that improve symptoms, quality of life, and survival. While most patients consult their general practitioner (GP) prior to HF, the early stages of HF may be difficult to identify. An integrated clinical support tool may aid in identifying patients at high risk of HF. We therefore constructed a prediction model using routine health care data. Methods Our study involved a dynamic cohort of patients (≥35 years) who consulted their GP with either dyspnoea and/or peripheral oedema within the Amsterdam metropolitan area from 2011 to 2020. The outcome of interest was incident HF, verified by an expert panel. We developed a regularized, cause-specific multivariable proportional hazards model (TARGET-HF). The model was evaluated with bootstrapping on an isolated validation set and compared to an existing model developed with hospital insurance data as well as patient age as a sole predictor. Results Data from 31,905 patients were included (40% male, median age 60 years) of whom 1,301 (4.1%) were diagnosed with HF over 124,676 person-years of follow-up. Data were allocated to a development (n = 25,524) and validation (n = 6,381) set. TARGET-HF attained a C-statistic of 0.853 (95% CI, 0.834 to 0.872) on the validation set, which proved to provide a better discrimination than C = 0.822 for age alone (95% CI, 0.801 to 0.842, P  & lt; 0.001) and C = 0.824 for the hospital-based model (95% CI, 0.802 to 0.843, P  & lt; 0.001). Conclusion The TARGET-HF model illustrates that routine consultation codes can be used to build a performant model to identify patients at risk for HF at the time of GP consultation.
    Type of Medium: Online Resource
    ISSN: 1460-2229
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 1484852-1
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  • 8
    In: EP Europace, Oxford University Press (OUP), Vol. 22, No. 5 ( 2020-05-01), p. 684-694
    Abstract: Atrial fibrillation (AF) is a common arrhythmia associated with an increased stroke risk. The use of multivariable prediction models could result in more efficient primary AF screening by selecting at-risk individuals. We aimed to determine which model may be best suitable for increasing efficiency of future primary AF screening efforts. Methods and results We performed a systematic review on multivariable models derived, validated, and/or augmented for AF prediction in community cohorts using Pubmed, Embase, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) through 1 August 2019. We performed meta-analysis of model discrimination with the summary C-statistic as the primary expression of associations using a random effects model. In case of high heterogeneity, we calculated a 95% prediction interval. We used the CHARMS (Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies) checklist for risk of bias assessment. We included 27 studies with a total of 2 978 659 unique participants among 20 cohorts with mean age ranging from 42 to 76 years. We identified 21 risk models used for incident AF risk in community cohorts. Three models showed significant summary discrimination despite high heterogeneity: CHARGE-AF (Cohorts for Heart and Aging Research in Genomic Epidemiology) [summary C-statistic 0.71; 95% confidence interval (95% CI) 0.66–0.76], FHS-AF (Framingham Heart Study risk score for AF) (summary C-statistic 0.70; 95% CI 0.64–0.76), and CHA2DS2-VASc (summary C-statistic 0.69; 95% CI 0.64–0.74). Of these, CHARGE-AF and FHS-AF had originally been derived for AF incidence prediction. Only CHARGE-AF, which comprises easily obtainable measurements and medical history elements, showed significant summary discrimination among cohorts that had applied a uniform (5-year) risk prediction window. Conclusion CHARGE-AF appeared most suitable for primary screening purposes in terms of performance and applicability in older community cohorts of predominantly European descent.
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2002579-8
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  • 9
    In: BMJ, BMJ
    Type of Medium: Online Resource
    ISSN: 1756-1833
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 1479799-9
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  • 10
    In: BMJ Open, BMJ, Vol. 11, No. 11 ( 2021-11), p. e055072-
    Abstract: To determine the accuracy of QT measurement in a smartphone-operated, single-lead ECG (1L-ECG) device (AliveCor KardiaMobile 1L). Design Cross-sectional, within-patient diagnostic validation study. Setting/participants Patients underwent a 12-lead ECG (12L-ECG) for any non-acute indication in primary care, April 2017–July 2018. Intervention Simultaneous recording of 1L-ECGs and 12L-ECGs with blinded manual QT assessment. Outcomes of interest (1) Difference in QT interval in milliseconds (ms) between the devices; (2) measurement agreement between the devices (excellent agreement 〈 20 ms and clinically acceptable agreement 〈 40 ms absolute difference); (3) sensitivity and specificity for detection of extreme QTc (short (≤340 ms) or long (≥480 ms)), on 1L-ECGs versus 12L-ECGs as reference standard. In case of significant discrepancy between lead I/II of 12L-ECGs and 1L-ECGs, we developed a correction tool by adding the difference between QT measurements of 12L-ECG and 1L-ECGs. Results 250 ECGs of 125 patients were included. The mean QTc interval, using Bazett’s formula (QTcB), was 393±25 ms (mean±SD) in 1L-ECGs and 392±27 ms in lead I of 12L-ECGs, a mean difference of 1±21 ms, which was not statistically different (paired t-test (p=0.51) and Bland Altman method (p=0.23)). In terms of agreement between 1L-ECGs and lead I, QTcB had excellent agreement in 66.9% and clinically acceptable agreement in 93.4% of observations. The sensitivity and specificity of detecting extreme QTc were 0% and 99.2%, respectively. The comparison of 1L-ECG QTcB with lead II of 12L-ECGs showed a significant difference (p= 〈 0.01), but when using a correction factor (+9 ms) this difference was cancelled (paired t-test (p=0.43) or Bland Altman test (p=0.57)). Moreover, it led to improved rates of excellent (71.3%) and clinically acceptable (94.3%) agreement. Conclusion Smartphone-operated 1L-ECGs can be used to accurately measure the QTc interval compared with simultaneously obtained 12L-ECGs in a primary care population. This may provide an opportunity for monitoring the effects of potential QTc-prolonging medications.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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